Labeler · US market

Burkhart Dental Supply Inc

Burkhart Dental Supply Inc is a US drug labeler with US FDA registrations covering 5 drug concepts (5 currently active) across 28 packages. It is currently the only active US supplier of 1 drug. The company files with FDA under 2 name variants, merged into this profile.

Also files as: Burkhart Dental Supply Co., Inc

ACTIVE — US

openFDA · updated weekly

Labeler codes43498

Active drugs5

Registrations28 active / 28

Packages28

Sole supplier of1 drugs

Portfolio5 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Sodium Fluoride gel	rx	12	12	SUPPLYING
Benzocaine gel	otc	10	10	SUPPLYING
Stannous Fluoride gel	otc	2	2	SUPPLYING
Stannous Fluoride concentrate	rx	2	2	SUPPLYING
Articaine Hydrochloride, Epinephrine Bitartrate injection, solution	rx	2	2	SUPPLYING

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

Articaine Hydrochloride, Epinephrine Bitartraterx

At a glance

TypeLabeler
Labeler codes43498
Filing names2
Drugs (active)5
Drugs (all time)5
US registrations28
Packages28

Recent events

Shortages, recalls, and registration changes across all filing names.

May 21, 2026
RECALLRecall (Class II): Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Sup…

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile (see “Also files as” above); figures cover the entity across all its filing names.